Reversal of Fortune

Although VaxGen’s much-hyped HIV vaccine flopped, the nearly 5,000 HIV negative gay men who tested it got excellent safe-sex counseling and support during the trial. So why did almost 300 hundred of them end up positive anyway?

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Four years ago, both Richard* and AIDSVAX were hopeful. The first HIV vaccine to reach Phase III trials, AIDSVAX was finally enrolling thousands of HIV negative gay men in 60 cities across North America (a few hundred women signed up as well). For several years, many had regularly reported the details of their sexual behavior, been tested for HIV and received safe-sex counseling as part of a massive study meant to prime just such a cohort. When the AIDSVAX trials finally opened, the participants were lauded as anonymous heroes in the search for a cure. “Rolling Up Their Sleeves to Take On a Killer,” proclaimed a New York Times headline, while another publication cheered “Silent Soldiers: The AIDSVAX Army.”

One enlistee was Richard, then 34. The handsome Manhattan architect and his equally handsome boyfriend, both HIV negative, shared a chic apartment and partied with the gay A-list. They didn’t use condoms with each other but did when they “had sex with different people every weekend,” Richard says. “It was always safe.” Still, his open relationship qualified him for the AIDSVAX trial. Richard got his first shot in May 1999. “I figured it was better than not trying something,” he says. “And they told me it was totally safe.”

But times have changed. In February, VaxGen, the California biotech company that developed AIDSVAX, released long-awaited data showing that the vaccine did not significantly reduce the risk of getting HIV: 5.7 percent of the subjects who received it got HIV—barely less than the 5.8 percent who took a placebo. When the company suggested that the vaccine might have worked better in the small number of black and Asian enrollees, whites accused VaxGen of trying to salvage a failed vaccine, and nonwhites accused whites of indifference to promising results for minorities. Data from an AIDSVAX study in Thailand, expected by year’s end, may yield more insight.

Richard found out he’d tested positive at his final study visit, in June 2002 on his lunch break. “I thought it would be like all the other times [I’d gotten results],” he says. “I was in denial.”

His seroconversion—and the nearly 290 others in the AIDSVAX trials—raise prickly questions. Mere participation in the study suggested these men already had a heightened awareness of HIV. Trial coordinators firmly told them that there was absolutely no guarantee that the vaccine offered any protection against the disease. And subjects were regularly and rigorously tested, queried and counseled in what many would call the gold-standard in prevention. Even if 290 seroconversions out of 5,000 participants doesn’t seem dramatic, in such a special group, why did anyone seroconvert at all?

STATS AND SLUTS

The AIDSVAX study embodied an ethical dilemma that will bedevil all HIV vaccine trials to come: It was obligated to counsel rigorously against unsafe sex, but researchers needed participants to have unsafe sex in order to weigh the vaccine’s effectiveness against a placebo. “Many of these men [who enrolled] tend to be engaging in risky sexual practices,” says Robin Miller, PhD, formerly of New York City’s Gay Men’s Health Crisis and now a psychology professor at the University of Illinois. “Men often came to GMHC hoping to learn that some breakthrough meant they didn’t have to use condoms religiously anymore.” His remarks echo a 2002 Canadian study finding that “gay and bisexual men who expressed willingness to participate in an HIV vaccine trial were more likely to be sexually risky.” Ricardo, a thirtysomething San Francisco bartender who seroconverted in the AIDSVAX trial, puts it this way: “Sluts make better study subjects.”

True? VaxGen rep Lance Ignon acknowledges that “high-risk behavior” was a desired criterion for participation—two out of five subjects initially reported regular unprotected anal sex with partners they knew to be HIV positive—but strenuously denies that VaxGen tacitly condoned unsafe sex. What’s more, trial researchers said from the beginning that earlier prevention studies left them expecting a certain number of infections, at the very least in the placebo arm. “If counseling alone was enough,” says Robert Hagerty, who helped run the trial site at New York University Medical Center, “we wouldn’t need a vaccine.”

Nor is it likely that the counselors, many of whom had long worked in gay men’s prevention, planted a mixed message. “I was told this was not an invitation to be unsafe,” says Jason, 25, a New Yorker who tested positive in the trial. The National Institute of Allergies and Infectious Diseases (NIAID) monitored VaxGen, and found that “all participants were strongly encouraged and supported in their efforts to reduce at-risk behaviors.” Corey, 30, one of the vast majority of participants who stayed HIV negative, says his San Francisco trial counselor “helped me work out a lot of thoughts” around his discomfort with anal sex—and realize, in the end, that “I’d much rather suck dick anyway.” VaxGen’s own data showed that the percentage of participants who first reported unprotected anal sex fell 50 percent by the study’s end.

Nonetheless, Walt Odets, a San Francisco psychotherapist and author of the 1995 book In the Shadow of the Epidemic, which has deeply influenced gay men’s HIV prevention, argues that rational thinking competes with “magical” thinking during sex. “We all have fantasies of omnipotence,” Odets says. “When you add to that even a tiny bit of a fact”—in this case, the off-chance of a protective vaccine—“it supports the fantasy.” Prodded, Jason says he may have felt “a little bit invincible, deep down.”

Odets, moreover, doubts “that these guys [in the trial] were exposed to very good prevention work. I would think it was conventional, informational—redundant for most of the guys in the trial.” For his gay male patients, he says, staying negative over the long term involves “talking about sex, death, love, longing—complicated stuff. Let’s say [the men in the study] had a half-hour of counseling every three months. That’s not much of an intervention.”

PLOT COMPLICATIONS

“He was so hot, I was drunk and stoned, it didn’t seem to matter.” That’s how Jason describes what he believes to be his moment of HIV exposure. Ricardo also downplays his infection. “I just don’t like condoms,” he says. “I’m so over having my sex life regulated.” But Hagerty warns against such simple explanations. “The way gay men have sex,” he says, “is very complicated.” Countless studies have documented the connection between HIV transmission and alcohol and drugs (crystal meth use in particular has surged among gay men). Then there’s intimacy and relationship issues, depression, the mood of the moment, and the feelings attached to the other person. Says Hagerty, “You simply can’t be 100 percent safe 100 percent of the time.”

Consider Richard, so scrupulously safe when he joined the trial. A few months later, he and his boyfriend were so deep in their addiction to crystal-fueled group sex that they were tossed out of their Fire Island summer share. By March of 2000, there was “such a big curtain between us sexually” that they broke up. Richard found himself alone, depressed, barely holding down his job, doing more crystal than ever. For the first time, he let someone he knew to be HIV positive come inside him. When he showed up for his study visit and HIV test a few weeks later, “I was a mess...even though the results were negative. ‘I hope this scares you,’ my doctor said. That little pep talk worked for a week. Then my denial came back. I thought, ‘Maybe the vaccine is working, or I’m fooling around with guys who are undetectable, or I have that special genetic trait.’” Richard believes his seroconversion happened the February after 9/11, after “an all-night orgy with two guys I allowed to fuck me several times, with orgasms.” Serostatus was never discussed.

Or take Frank, 30, a New York City realtor who lost his job and then his apartment shortly after enrolling in the trial. “I fell into a black hole,” he says. “Nothing seemed important. I might as well have died, for all I cared.” He went on a long drinking binge, having unsafe sex with lots of men whose names he never knew. “It was like Dr. Jekyll and Mr. Hyde. During the day, I’d go to NYU to get my shots and dose of counseling. And at night, I was at [the Manhattan bath house] the West Side Club.”

By studying these scenarios, researchers are forging new avenues of HIV prevention. Hagerty and his colleagues at NYU have started a follow-up study to the AIDSVAX trial to explore “the connection between depression and risky sex in gay men.” With the help of 110 HIV negative volunteers, all of them AIDSVAX veterans, they’re trying to find out if treating clinically depressed men with an antidepressant and counseling can help them stay safer. “If we find that treating depression helps people reduce their HIV risks, then this...could become part of standard HIV testing and counseling,” Hagerty suggests.

GOING DEEPER

Still, these new insights arrive at a queasy time for traditional gay men’s HIV prevention, as infection rates rise and the Centers for Disease Control and Prevention (CDC) proposes moving federal prevention money from community organizations to a national HIV-testing initiative. Do the experiences of Richard, Jason, Ricardo and Frank—who seroconverted despite the very sort of counseling many community groups offer—support the oft-heard claim that prevention as we know it has failed? Or do they suggest that prevention must address a changed world?

Ten years ago, there was no Internet to facilitate sexual encounters, no crystal-meth epidemic to disinhibit a generation of men who grew up terrified of condomless sex, and no med cocktails to lessen HIV’s near-certain death sentence. “I knew things were different even when I started the trial,” Richard says, “and while I had no desire to get HIV, I never thought I’d drop dead.” Says Ricardo, “So now I have to take a few pills. Fine.”

His remark may infuriate longtime HIVers who’ve suffered despite and because of those few pills, but it suggests a re-examination of why someone would want to stay HIV negative today. Especially young men, who may not think about their lives beyond the next few years. “I ponder this a lot,” Odets says. “The incentive is reduced. But I have young patients who abhor the idea of contracting HIV. I think they would experience it as a failure and embarrassment in terms of family and friends.” AIDSVAX vet Corey says he’s glad he’s still negative and intends to stay that way: “I won’t have to deal with meds, the stigma attached, the emotional baggage.”

That’s a message more HIV negative men need to hear, says Odets. “We’ve normalized having HIV, which I think is helpful to positive men, but then what’s the basis for telling other people to avoid it?” He says that for HIV prevention to stay effective it needs to push beyond “information” campaigns and tackle issues that belong more in the realm of the therapist’s couch, like self-esteem and internalized homophobia. “When people feel better about themselves,” he adds, “about their potential for a meaningful relationship or work, they take better care of themselves.”

Group-oriented models—which pull gay men out of isolation and into a community—are another approach. In such settings, Odets says, gay men “learn about how they affect people, how people affect them, how to communicate—it’s a little model for society.” He says the San Francisco prevention group Stop AIDS Project (www.stopaids.org) has asked him to lead a group for HIV negative men this fall. And he points to the Seattle agency Gay City Health Project (www.gaycity.org), which invites gay men to not only sign up for its campaigns but to help create them.

Fred Swanson, Gay City’s executive director, recalls a recent conversation with a program volunteer, a 32-year-old HIV negative man who’d been having risky sex. Says Swanson, “He told me that before he got involved [with us], he hadn’t understood what it meant to be part of the gay community, that his only way of finding the connection that he longed for was hooking up. He felt like his life wasn’t valuable. Gay City showed him that he belonged to something greater. He’s had a loss of desperation.”

Still, Gay City’s approach demands frank talk about gay sex—the kind of candor that many say has led conservative lawmakers to goad the CDC into conducting two aggressive audits in the past year of the federally funded Stop AIDS, also known for its provocative programs. Cherishing its freedom, Gay City has stopped requesting federal funds, getting by on state and city dollars, plus research grants. But other groups may not survive without that money, especially those serving low-income gay and bisexual men of color, whose rates of new HIV infections make AIDSVAX’s 290-some seroconversions look like small change.

Meanwhile, Richard has lost his own desperation, which he credits to the wake-up call of his HIV diagnosis. The next day, he entered recovery. Today, he’s happily employed again, attends church weekly, and has started a “mature, loving and completely monogamous” relationship with an HIV negative man.

Does he regret getting HIV? “It’s hard to regret something that’s had such positive outcomes,” he muses. “I’m not on meds yet. Ask me that when I have my first side effects or signs of the disease. Right now I’m just sort of benefiting from it.”

* some names have been changed

TRIAL AND TRIAL AGAIN

VaxGen’s vision may be a bust, but it’s not the end of HIV vaccine research—or good prevention:

LOCAL HEROES Neggies (guys and gals), check out www.avac.org; search “HIV vaccine” at www.clinicaltrials.gov;or call 1.800.448.0440 to connect to trial sites in your area for newvaccines. HIVers can do the same for “therapeutic” vaccine trials thatmay help fight the virus.

HERPES HELPERS HIV negative gay guys in New York, SanFrancisco and Seattle with genital herpes: Keep an eye out for adsannouncing a study to assess the effectiveness of daily acyclovir atpreventing HIV infection.